Patricia Amtower v. Allergan, Inc., et al.
Published: Nov. 16, 1996 | Result Date: Aug. 2, 1996 | Filing Date: Jan. 1, 1900 |Case number: 735065 – $0
Judge
Court
Orange Superior
Attorneys
Plaintiff
Defendant
Jamie L. Wine
(Latham & Watkins LLP)
Experts
Plaintiff
James Grisolia
(medical)
Alice Matoba
(medical)
Dean C. Delis Ph.D.
(medical)
Sharon Reed
(medical)
Phil Don Whiteman
(technical)
Defendant
Sheldon E. Jordan
(medical)
Richard B. Cooper
(technical)
Louis Wilson
(medical)
Facts
Plaintiff Patricia Amtower, a 52-year-old senior regulatory affairs manager was employed by defendant Allergan, Inc. (Allergan) from 1982 until August 1993. In late summer 1992 Allergan's marketing department desired to remove a plastic lens cleaning case from the retail package of one of its contact lens cleaning and disinfecting products. Allergan claimed it did not believe a new lens case was necessary to be used with each purchase of the disinfecting solution. Thus, Allergan desired to remove the lens case, in part to reduce the cost of goods associated with the product. Allergan claimed it planned to make the lens cup available to consumers free of charge through other means. From January to May 1993, the plaintiff was consulted by Allergan's regulatory affairs manager in change of the product at issue. The plaintiff informed the marketing department that she believed FDA regulations required Allergan to obtain prior approval from the FDA (via a PMA supplement). The plaintiff claimed she believed that to do otherwise would have been in violation of the law. Other members of the product team (including the plaintiff's supervisor) claimed they believed that the change could be made without filing a PMA supplement, since it would not impact the safety or efficacy of the product, and the FDA could simply be notified by a letter. (A formal PMA supplement could take a year or so to process, delaying Allergan's ability to make the desired packaging change.) The plaintiff claimed the letter notification procedure did not exist under the regulations. At a meeting of all team members in September 1992, the plaintiff stated her objections, but claimed she was ultimately pressured into acquiescing with the team's decision not to file a PMA supplement. The plaintiff claimed she was concerned that removing the lens case from the retail package might affect the safety of the product, since the lens cases would no longer be replaced with each purchase. On Oct. 20, 1992, the plaintiff submitted a PMA supplement with the FDA, despite the product team's decision not to do so, seeking prior approval to remove the lens case from the retail package. The defendants claimed the PMA supplement filing caused a delay in Allergan's marketing plan and resulted in hundreds of thousands of dollars in unanticipated production costs. The plaintiff claimed that at the time she filed the supplement, she was confident that FDA approval would be obtained by April 1993, in time to meet Allergan's marketing plan. In late 1992, the plaintiff was promoted to a different regulatory affairs position and no longer had responsibility for the product. In March 1993, the plaintiff was mildly criticized in her work performance evaluation for her failure to communicate with other members of the product team before making the decision to handle the FDA approval process differently from the manner previously agreed upon. The plaintiff's overall evaluation was very good (a four out of of five) and she received a $5,000 per year pay raise. Shortly after the work performance evaluation, a dispute arose between the plaintiff and her supervisor concering a proposed letter to be sent to the FDA by the Allergan regulatory affairs manager handling the product at that time. Allergan's human resources department intervened and several meetings were held between the plaintiff, the human resources manager and the plaintiff's supervisor. During the course of these meetings, the plaintiff claimed she became aware of what she believed was a conspiracy, on the part of several of Allergan's highest-ranking managers, to cover up a safety problem associated with the lens cup. Allergan had received some complaints from consumers that, after storing their lenses in the solution in the lens cases for extended periods of time, mold appeared. The plaintiff claimed that, in May 1993, she discovered that the lens case was being infected by a fungus at the manufacturing plant in Taiwan ****
Settlement Discussions
The plaintiff made a C.C.P. º998 settlement demand for $3 million. The defendants made a no C.C.P. º998 offer of compromise.
Specials in Evidence
$_________ $________ $900,000 to $1.2 million $_______
Damages
The plaintiff claimed economic and non-economic in the amount of $1.8 million and punitive damages.
Injuries
The plaintiff alleged she suffered emotional distress and physical injury (a post-resignation stroke).
Result
***CONTINUATION OF FACTS: the fungus complained of by customers was the same fungus. Allergan claimed that this not a safety problem and that Allergan did not attempt to conceal it from the FDA. Allergan claimed that it investigated the mold complaints and determined that the mold occurred largely due to patient's failure to follow lens case cleaning directions. A few months after these meetings, in August 1993, the plaintiff resigned. When she did, Allergan allegedly pleaded with her to reconsider, but to no avail. The plaintiff brought this action against Allergan, Richard Courtney, Paul Nowacki and four other Allergan executives, based on constructive discharge and retaliation theories of recovery. Allergan cross-complained against the plaintiff, for breach of employment contract, arising from the plaintiff's allegedly unauthorized misappropriation of Allergan documents. The cross-complaint was voluntarily dismissed before trial. @@ CONTINUATION OF CONTENTIONS would have put the plaintiff's in a compromised position which may include criminal sactions. The plaintiff's resigned to avoid implication and ongoing criminal activity. At trial it was undisputed by all medical experts that fungal contamination in the contact lens case increases the risk of potential ocular infection, including corneal ulcers. The defendants contended that they followed all of the approriate FDA regulatory procedures in implementing the corrective action measures, including notifying the FDA of each change. The defendats also contended that the FDA conducted an on-site surprise inspection in the fall of 1993, based on an anonymous tip (which the plaintiff admitted to initiating) and concluded that Allergan had followed correct regulatory procedures. The defendants further contended that the spector of criminal liability was sensationalism on the part of the plaintiff, since even if regulartory violations had occurred as the plaintiff had alleged, such violations would have been technical in nature -- not the kind that typically result in an FDA enforcement action. The defendants argued that the palintiff was immune from any legal liablity under the law, as she was no longer responsible for the product.
Other Information
The verdict was reached approximately one year and eleven months after the case was filed. A settlement conference was held on June 25 through June 27, 1996 before Judge Thomas Thrasher of Orange County Superior Court. It failed to resolve the matter. Prior to trial, the defendants obtained summary adjudications in their favor as to breach of contract and intentional infliction of emotional distress. After the plaintiff's dismissal of four of her remaining claims, the only three claims which proceeded to trial were the claims for constructive discharge in violation of public policy and breach of contract and fraud and deceit. Pursuant to directed verdicts, the only claim proceeding to the jury was the constructive discharge claim. Per the plaintiff, the pivotal issue was whether the plaintiff was in a "responsible position" which would subject her to criminal prosecution by the FDA, under U.S. v. Parks line of cases.
Deliberation
2+ days
Poll
9-3
Length
18 days
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